FDA Warns That Antibiotic Tygacil Shows Raised Death Risk
The antibiotic Tygacil is linked to an increased chance of death when used to treat serious infections, the U.S. Food and Drug Administration said Friday.
In issuing a black box warning, the agency asked that physicians limit their use of the intravenous medication.
Labeling for the Pfizer drug will now state that the medicine "should be reserved for use in situations when alternative treatments aren't suitable."
The warning is based on a new analysis that showed 2.5 percent of patients receiving Tygacil died, compared with 1.8 percent of patients receiving other antibiotics.
Pfizer said in a statement it will update the labeling, Dow Jones reported. "Pfizer encourages health care professionals to review all available information to find an antibiotic therapy that works best for each patient's clinical situation," the company said.
Approved for the treatment of a specific type of pneumonia and certain skin and intra-abdominal infections, Tygacil is not approved to treat diabetic foot infections or for hospital-acquired or ventilator-associated pneumonia. In 2012, sales of the drug surpassed $335 million, Dow Jones reported.
The agency's concerns with Tygacil first surfaced in 2010, when the FDA warned of an increased risk of death in clinical studies. Since then, the agency has analyzed data from 10 trials to arrive at the decision to issue a black box warning.
"In general, the deaths resulted from worsening infections, complications of infection or other underlying medical conditions," the agency said.
Posted: September 2013